The Silicone Injection Story for Corns

The silicone experiment

 

This article is a memorial to a US Podiatrist who attempted to provide a one-time cure for corns, but sadly became obsessed with a treatment that failed to have scientific scrutiny. Reviled by many of his USA colleagues, the author and colleague, Damian Holdcroft, set out to work with Dr Balkin in the UK, to review his method as recommended between 1995-8. Their work and findings were finally published in 2001. This article is taken from Foot Health Myths, Facts, and Fables 2021. Published by Busypencilcase Communications & Publishing.

Sol Balkin DPM

The work of Dr Sol Balkin[1] has passed into podiatric history for two reasons. Firstly, because the method he applied worked for him, but secondly, when tested under strict scientific conditions the method failed. It is a tale that is hidden from the public and to some extent few will know of the case.

Balkin was an American podiatrist from Glendale, California, and spent most of his career developing a method to replace lost fat in the foot. It was his aim to cure corns and callus. In this respect all podiatrists yearned for that magic cure. Doubtless, Balkin (1915-1994[2]), benefitted many patients. His ideas were of concern because of the unknown effects of silicone within the lymphatic system as well as uptake of unwanted particles in the liver.

A Company called Biodermis (US), supported Balkin to launch the product in the UK but required the manufacture of the medical grade silicone to be approved under the European Union in Eire. The work was conducted at a podiatry centre in the Midlands, UK with full ethical approval and later published in a scientific journal in 2001[3].

Scientific Analysis of Silicone Injection for corns

Having been informed that a medical grade silicone could cure corns under the ball of the foot based on longstanding work by Balkin (1972), a trial using two groups was set up to record results. This has the name PROSPECTIVE as opposed to retrospective, where this type of study reviews older data accepting flaws in study design which cannot be controlled.

A control group – (A - water) and an active group (B  -medical grade silicone) were designed. The two products were randomly allocated to reduce bias so the volunteer patient did not know whether they would receive dose A or B.

After several injections, the volunteers were followed up and photographs shown to an independent scrutineer. The volunteers all returned their final opinion based on pain experienced and how they felt about their treatment and if the corn had been cured.

Random biopsies were taken to consider the effect of silicone and ensure no active inflammatory changes arose. Biopsies were conducted by punching a 3mm piece of skin from the area, which is a little like taking a sample of water to see if it is contaminated. The results showed water was no more or less effective using an agreed dose of injected silicone. The trial successfully demonstrated the limits of silicone for corns on the sole of the foot.

Two further findings arose

Where silicone was injected in toes, the results were much better, but the numbers studied were too low to be reliable. It is likely, had more funding, time and subjects been made available, Balkin’s original work may have gained acceptance within the medical community.

Moral of the tale

Ten years on, two of the volunteers required surgical removal of the silicone from their feet because the ingredients caused deep tissue reaction. Fifteen years on a further patient required the silicone removing. And, so we learn -  following the science has many aspects.

It can teach us much if the experiment known as a trial is performed ethically and to a high standard.

The second most important aspect relates to following volunteers for long enough after trials because in the final analysis we have to look at the risks as an unwanted byproduct. In the case of dermal silicone injections for corns, the benefits could have been huge and the profits from developing this high.

Epitaph

Sadly Balkin died with deep disappointment that his personal project, one that had taken him many years of development, suffered from an outcome that he had not predicted. It took courage to try to help patients and there was nothing mischievous or intentionally wrong or even unethical. All Balkin’s patients consented, but the level and degree of consent in the 21st century is at a very high ceiling today. The UK trial was undertaken with Balkin’s full permission and he demonstrated his technique to us. Balkin’s original success required large volumes of silicone to work on the sole and offered impressive photographic results originally. However, he had never subjected his work to the rigours of a scientifically controlled medical trial until the UK study. If an experiment cannot be repeated faithfully by an independent observer then the method or science must be questioned.

One does not need to be medically trained or have vast scientific knowledge to appreciate how the Corona virus vaccination process has been rolled out to millions, with concerns over small numbers of fatality. Humans place a high store on safety and this is unlikely to diminish.

[1] Balkin, SW Plantar keratoses: treatment by injectable liquid silicone. Report of an eight-year experience. Clin Orthop Relat Res. 1972 Sep;87:235-47.

[2] The citation of Balkin’s death is probably inaccurate as the author did not start work with Balkin until 1995-6.

[3] Tollafield DR, Holdcroft DJ, Singh R, Haque MS. Injectable Percutaneous Polydimethicone in the Treatment of Pedal Keratomas: A Single Blind Randomized Trial. Foot and Ankle Surgery. 2001. 40(5):295-301

Thanks for reading the Silicone Injection Story for Corns by David R. Tollafield

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